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Clostridium Difficile (C. Difficile) clinical trials at UC Health

1 research study open to eligible people

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  • An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection

    open to eligible people ages 18 years and up

    This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 6 mg/kg BW/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts. In Part 1 of the study, 10 subjects of either sex with non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe CDI will be enrolled and randomized in a 2:1 ratio to receive DNV3837 or SOC. In both parts of the study, treatment infusions will be administered at a constant rate of 0.5 mg/kg BW/hour, resulting in a total IV infusion duration of 12 hours per day, for a total daily dose of 6 mg/kg BW DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are: - To evaluate the safety of intravenous (IV) DNV3837; - To evaluate the efficacy of IV DNV3837 versus standard of care (SOC); - To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces; - To assess C. difficile using microbiological assessments; - To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and - To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis

    at UC Davis UCLA

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